FDA Adverse Event Death Summary report: N

E Z LIFT

MDR report key: 372549 · Received January 23, 2002

Report

Report Number: 372549
Event Type: Death
Date Received: January 23, 2002
Date of Event: December 11, 2001
Manufacturer: EZ WAY INC
Product Code: FNG
Report Source: User Facility report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

RESIDENT WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR WITH 2 NAR'S. NAR'S PLACED SLING AND ATTACHED SLING TO DEVICE. PRIOR TO USE BOTH NAR'S CHECKED POSITION OF SLING AND DID A 4 POINT CHECK OF STRAP ON E-Z LIFT ARM. RESIDENT HAD BEEN LIFTED UP FROM BED AND WAS MID TRANSFER POINT. ONE NAR WAS AT E-Z LIFT CONTROLLING DEVICE, THE 2ND NAR BY RESIDENT'S SIDE. 2ND NAR TURNED THEIR UPPER BODY (NOT RESIDENT) TO CHECK PLACEMENT OF WHEELCHAIR. RESIDENT HAD SUDDEN WEIGHT SHIFT IN SLING, FALLING BACKWARDS. TOP LOOPS OF SLING POPPED OFF (DID NOT TEAR OFF). RESIDENT FELL DOWN TO FLOOR LANDING ON LEFT SIDE OF FACE AND HEAD AND THEN TO LEFT SHOULDER.

Description of Event or Problem · 1

ADD'L INFO REC'D FROM MFR 03/15/2002: MFR'S REGULATORY SALES MGR MET WITH ADMINISTRATOR, DIRECTOR OF NURSING AND THE TWO CERTIFIED NURSING ASSISTANTS THAT WERE USING THE LIFT WHEN THE ACCIDENT OCCURRED. TO THE BEST OF THEIR KNOWLEDGE, THE ONLY POSSIBLE EXPLANTATION FOR THE CAUSE OF THE ACCIDENT(THE SLING BECAME DISCONNECTED FROM THE LIFT DURING THE TRANSFER) WAS OPERATOR ERROR. THERE WAS NO DAMAGE TO THE LIFT OR THE SLING ACCESSORY. IT WAS CONCLUDED BY ALL PARTIES THAT THE LIFT DID NOT MALFUNCTION. THIS IS REINFORCED BY THE FACT THAT THE LIFT WAS KEPT IN SERVICE AT THE FACILITY. THEREFORE, THE ACCIDENT WAS THE RESULT OF IMPROPER OPERATION OF THE LIFT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	E Z LIFT	PATIENT LIFT DEVICE	FNG	EZ WAY INC	796	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Death\| H\| L